Tightening government control over the sale of medical devices, Korea is now setting up an authorized period of time that devices can be offered for sale before their registration needs to be renewed. Under the new rule published by Korea’s Ministry of Food and Drug Safety in April and slated to go into effect in October, medical device authorizations will now be valid for five years. Until now, marketing authorizations for medical devices never expired.
The new requirement is not yet applicable to devices already registered and authorized for sale in Korea. But a revision to the law to cover devices with existing authorizations is expected soon.